Duns Number:025460908
Device Description: NS ISOLATION KIT
Catalog Number
DYK1011914I
Brand Name
Medline Industries, Inc.
Version/Model Number
DYK1011914I
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OEA
Product Code Name
Non-surgical isolation gown
Public Device Record Key
37937191-f63e-4698-b5f8-b58091186693
Public Version Date
June 17, 2022
Public Version Number
4
DI Record Publish Date
August 28, 2018
Package DI Number
40884389479781
Quantity per Package
15
Contains DI Package
10884389479780
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |